The Supreme Court of the United States in Merck KGaA v. Integra LifeSciences I, Ltd., 125 S.Ct. 2372 (June 13, 2005), reversed the United States Court of Appeals for the Federal Circuit in a 9-0 decision. By giving a broad interpretation of the "safe harbor" provision of 35 USC 271(e)(1), pharmaceutical companies (both pioneers and generics) are in a position to use and experiment with the inventions of others as part of their research programs. This presentation will explore how this important decision impacts (1) the ongoing struggle between pioneer pharmaceutical companies and the generic drug companies, (2) the impact on biotech and other companies that offer "research tools," and (3) efforts by the Federal Circuit to establish a uniform national body of patent law.
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